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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K201914
Device Name HRVWatch-Mini Wrist Monitor
Applicant
Taiwan Scientific Corporation
10f, 88-4, Ming-Chiuan Rd., Shin-Dian District
New Taipei,  TW 23141
Applicant Contact D.C. Sun
Correspondent
Taiwan Scientific Corporation
10f, 88-4, Ming-Chiuan Rd., Shin-Dian District
New Taipei,  TW 23141
Correspondent Contact D.C. Sun
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DPS   DXH  
Date Received07/09/2020
Decision Date 06/07/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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